Bioabsorbable rivet bone fastener

ABSTRACT

Bone fasteners consisting of a rivet and an expansion pin for attaching soft tissue and bone plates to bone. The rivet has an enlarged proximal end, a tubular body portion dimensioned to fit snugly within a hole drilled in a bone, and a distal end having expandable legs. The expansion pin is either slidably or rotatably mounted within an axial bore in the rivet. In a first embodiment, the expansion pin has a metallic traction portion and a conical, preferably bioabsorbable, distal end portion releasably affixed thereto. In use, the rivet is inserted into a pre-drilled hole in a bone. When tension is applied to the traction portion of the expansion pin, the conical end portion progressively advances into the bore thereby forcing the legs on the distal end of the rivet to expand outwardly. When the legs are fully expanded, further progress of the conical portion is arrested by a shoulder stop within the axial bore. Further tension on the traction portion breaks the expansion pin, leaving the conical distal end within the expanded bore. In a second embodiment, a conical expansion pin is pressed into the rivet&#39;s axial bore from the proximal end of the bore. In a particularly preferred embodiment, rotation of an expansion pin housed within the rivet&#39;s axial bore exerts an outwardly directed force on the legs. When the legs are sufficiently expanded, a groove detent within the bore resists further rotation of the expansion pin. All embodiments of the rivet bone fasteners can be adapted for compression reduction of a fracture. With all embodiments of the bone fasteners, both the rivet and the expansion pin, or portions thereof, may be fabricated from either bioabsorbable or nonabsorbable materials, the choice of material depending on the application.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to fasteners for attaching a substrate to a bone,and more particularly to fasteners for anchoring soft tissue or boneplates to bone.

2. Prior Art

Both bioabsorbable and nonbioabsorbable bone fasteners adapted forattaching bone plates and soft tissue, such as, for example tendons andligaments, to bone are known in the art. Such prior art fastenersinclude staples and tacks, screws, and rivets. Examples of staple typefasteners are illustrated in U.S. Pat. Nos. 4,454,875 and 4,570,623.Such bone staples generally include barbs on the cross-member which areuseful for securely grasping a soft tissue such as a ligament andattaching it to bone.

The second type of fasteners include both screws and screw-washercombinations wherein a hole must be drilled in a bone for the purpose ofreceiving the screw. Screws may be fabricated from a surgicallyacceptable, biocompatible metal such as titanium, stainless steel or acobalt-chromium alloy. Such metallic screws may be self-tapping. In bonefasteners comprising a screw-washer combination, the washer has spikeson one surface operable for grasping tissue, and a central aperturethrough which the screw is inserted into a bone. If the screw isfabricated from a bioabsorbable material, the hole in the bone must betapped before the screw can be urged thereinto. Other ligament anchoringsystems are disclosed in U.S. Pat. Nos. 4,927,421 and 4,870,957.

The staple and screw types of bone fastening devices possess severaldisadvantages. For example, staples, which are meant to be hammered intobone, must be made of a strong material, such as a metal. The use ofstaples is time consuming, traumatic and precludes the use ofbioabsorbable polymers as suitable material for staple-type fasteners.As with staples, until such time as stronger and harder bioabsorbablematerials become available, self-tapping screws must comprise abiocompatible metal. Both regular and self-tapping screw fastenersrequire a hole be drilled in the bone prior to use, If the screwcomprises a non-metallic bioabsorbable material, the hole must also betapped in order to receive the screw which requires an additional timeconsuming step.

In accordance with current art, metallic staples and screw fasteners areeither permanently implanted within a bone, or a second surgicaloperation must be performed in order to remove them. In either case,implantation of metal fasteners does not allow for the gradual transferof stress back to the bone/soft tissue junction as the healing proceeds.This, in turn, may slow down or impede the healing process. Furthermore,metal screws and staples may migrate from their original site ofimplantation over a period of time and lodge in a tissue causing pain.Permanently implanted metallic screw and staple fasteners can evenmigrate from the site of implantation to lodge within a joint, creatingsignificant damage to articulator cartilage and other structures.

To overcome the disadvantages of the screw and staple types of bonefasteners, expandable rivets, both bioabsorbable and metallic, have beendeveloped. Examples of such rivets are disclosed in U.S. Pat. Nos.5,968,044; 5,911,721; and 5,725,529 to Nicholson et al., and U.S. Pat.No. 5,720,753 to Sander et al. Such rivets, which are eitherbioabsorbable or metallic, have the advantage that they may be insertedinto an untapped hole, thereafter to be expanded, thereby reducing thetime required for implantation of the rivets. Prior art rivets includean elongate body portion having an axial bore, an expanded head portionand an expandable leg portion. All of the prior art rivet-type bonefasteners include an expansion pin slidably mounted within the axialbore of the rivet. The bore and a portion of the expansion pin areconfigured such that movement of the expansion pin in an axial directionforces apart two or more legs on the rivet. The outer surface of thelegs is adapted to engage the surrounding bone thereby preventing therivet from backing out of the hole following implantation. The rivetsinclude means for fastening a substrate to the rivet.

The expansion pins or functionally similar slidable elements used toexpand the legs of the rivet bone fasteners, in accordance with theprior art, include a break-away portion which is not implanted in thebone with the rivet. On certain embodiments of the prior art rivets,tension must be applied to the expansion pin in order to expand the legsof the rivet. The tensile strength required to separate the tractionportion of the expansion pin from the conical end portion may vary. Suchtension may either pull the rivet out of the hole or cause the expansionpin to break prematurely. so that the security of the rivet within thebone is compromised.

Conversely, in other embodiments of the prior art rivets, the expansionpin is advanced into the rivet's axial channel in a distal direction(ie: deeper into the hole) to expand the legs. The expansion pin isurged into the axial channel by means of an insertion tool which isaffixed to the expansion pin by frangible means. In the event that theinsertion tool prematurely breaks away from the expansion pin, the rivetmay not be securely anchored within the hole and prove difficult toremove. Accordingly, there remains a need for a fastener for securingtissue to bone which will have a predictable and sufficient initialanchorage strength to permit gradual load sharing to provide full repairand restoration of function of the tissue and bone. There exists afurther need for a fastener device which is easily and rapidly attachedto tissue and can be reliably anchored into bone which will not pull outof the bone or migrate from its original position followingimplantation.

SUMMARY OF THE INVENTION

Rivet bone fasteners are provided in accordance with the presentinvention which are operable for attaching either an autogenoussubstrate such as tissue, or an exogenous substrate such as a boneplate, to a bone. Embodiments of the rivet bone fasteners are adapted tomeet the variety of demands presented by various surgical proceduresemployed during orthopedic, plastic and reconstructive surgery. Therivet bone fasteners of the present invention include absorbable,nonabsorbable and hybrid embodiments.

It is a first object of the invention to provide a device which may beused to attach a material substrate to a bone.

It is a further object of the invention to provide a bone fastenerdevice which may be anchored securely in an untapped hole drilled in abone.

It is another object of the invention to provide a bone fastener devicemeeting the above objectives which may be permanently implanted in abone and which will remain anchored in bone after implantation.

It is yet a further object of the invention to provide a bone fastenerwhich may be either non-absorbable, partially absorbable or totallyabsorbed by the body following implantation therein.

It is yet another object of the invention to provide a rivet bonefastener adapted for insertion into a hole in a bone, thereafter to beexpanded to provide non-releasable engagement of the rivet with the wallof the hole.

The features of the invention believed to be novel are set forth withparticularity in the appended claims. However the invention itself, bothas to organization and method of operation, together with furtherobjects and advantages thereof may be best be understood by reference tothe following description taken in conjunction with the accompanyingdrawings in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a rear loading rivet bone fastenerin accordance with the present invention.

FIG. 2 is a end view of the distal end of the rivet bone fastener ofFIG. 1.

FIG. 3 is a end view of the proximal end of the rivet bone fastener ofFIG. 1.

FIG. 4 is a longitudinal cross-sectional view of a rear loadingexpansion pin used to expand the rivet bone fastener of FIG. 1.

FIG. 5 is a distal end view of the expansion pin of FIG. 4.

FIG. 6 is an enlarged view of the outer surface of the rivet bonefastener of FIG. 1 illustrating a modification of the outer surface ofthe rivet for securely gripping a bone.

FIG. 7 is a distal end view of the top-loading embodiment of a rivetbone fastener shown in further detail in FIGS. 8 and 9.

FIG. 8 is a elevational cross-sectional view, taken along section line8—8 of FIG. 7, illustrating a top-loading embodiment of a rivet bonefastener in accordance with the present invention.

FIG. 9 is a proximal end view of the rivet bone fastener of FIG. 7.

FIG. 10 is a cross-sectional elevational view of a top loading expansionpin adapted for use with the rivet bone fastener of FIG. 7.

FIG. 11 is a proximal end view of the top loading expansion pin of FIG.10.

FIG. 12 is a distal end view of a particularly preferred embodiment of arivet bone fastener shown in further detail in FIG. 13.

FIG. 13 is a longitudinal cross-sectional view, taken along section line13—13 of FIG. 12 illustrating a particularly preferred embodiment of abone rivet in accordance with the present invention wherein the legscomprising the rivet are expanded by means of a rotational expansionpin.

FIG. 14 is a proximal end view of the rivet of FIGS. 12 and 13.

FIG. 15 is a longitudinal elevational view of a rotatable expansion pinin accordance with the present invention adapted for use with the rivetof FIG. 12.

FIG. 16 is a distal end view of the expansion pin of FIG. 15.

FIG. 17 is a cross-sectional side view of a bone compression rivet inaccordance with the present invention.

FIG. 18 is a cross-sectional view of a bone fracture site illustratingthe use of a compression rivet and a compression washer to stabilize andcompress the fracture site.

FIG. 19 is a top view of a compression washer adapted for use with thecompression rivet of FIG. 17.

FIG. 20 is a cross-sectional view, taken along section line 20—20 ofFIG. 19, illustrating the locking flanges adapted to lockingly engage acompression rivet.

FIG. 21 is a partially cutaway elevational view of a rivet insertiontool adapted for inserting a top loading rivet into a hole drilled inbone and forcing a top loading expansion pin into the axial bore of therivet to expand the legs of the rivet.

FIG. 22 is a schematic left end view of the rivet insertion tool of FIG.21.

FIG. 23 is a right end view of the rivet insertion tool of FIG. 21.

FIG. 24 is a side elevational view of an expansion pin insertion rodadapted for use with the rivet insertion tool of FIG. 21.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The term “bioabsorbable material” or “bioabsorbable”, as used herein,means that the referenced material is biocompatible, and that at least aportion of the material is either excreted or assimilated by the bodyfollowing implantation therewithin. Turning now to FIG. 1, a expandable,rear-loading rivet bone fastener 10 has a proximal head portion 11, adistal end 12 and a body portion 13 therebetween. The rivet bonefastener 10 has an interior cylindrical bore 14 coextensive with thelength thereof having a shoulder 15 therewithin. The distal portion 12of the body portion 13 includes at least two expandable legs 16 a and 16b (only one leg 16 a is shown in FIG. 1 due to the cross-sectional view)having at least one slot 17 a therebetween. In the embodiment of therivet shown in FIG. 1, there are an additional pair of expandableopposing legs separated by slot 17 b. The cylindrical bore 14 tapersoutwardly between the shoulder 15 and the distal end 12 forming aconical aperture 14′ in the distal end 12 which is coaxial andconcentric with the axial bore 14. The distal end 12 and the proximalend 11 of the rivet 10 are shown in end view, in the direction of theaxial bore 14, in FIGS. 2 and 3 respectively.

An expansion pin 40 for use with the rear-loading rivet 10 describedabove, is shown in longitudinal cross-sectional view in FIG. 4. Theexpansion pin 40 comprises an elongate cylindrical core 41, preferably alength of a metallic wire, having a proximal end 42 and a distal end 43.The distal end 43 of the core 41 is surrounded by a conical expanderportion 44 having an abrupt shoulder 45 on the proximal end thereof. Theconical expander portion 45 comprises a structural material which isdifferent from the structural material comprising the core 41, and ismost preferably a bioabsorbable material. Suitable materials forfabricating the conical expander portion 44 include polymer blends ofglycolide and/or lactide homopolymer, copolymer and/or glycolide/lactidecopolymer and polycaprolactone copolymers, and/or copolymers ofglycolide, lactide, poly(L-lactide-co-DL-lactide), caprolactone,polyorthoesters, polydioxanone, trimethylene carbonate and/orpolyethylene oxide or any other bioabsorbable material. The outersurface of the conical expander portion may comprise means forpositively engaging the wall of the rivet's axial bore 14 in order toprevent backward motion of the expansion pin within the axial bore. Aright end-on view of the conical expansion pin 40 is shown in FIG. 5.

In order to use a rivet type of bone fastener in accordance with thepresent invention, a hole is first drilled in a bone at a site where asubstrate such as soft tissue or a bone plate is to be attached. Thecore 41 of the expansion pin 40 is dimensioned to slidably fit withinthe axial bore 14 of the rivet 10. The proximal end 42 of the expansionpin 40 is inserted into the distal end 12 of the axial bore 14 in therivet 10 and urged thereinto until the conical portion of the expansionpin is snugly lodged within the axial bore and cannot be furtheradvanced without expanding the legs 16 of the rivet. The distal end 12of the rivet is inserted into the hole and advanced until the proximalhead end 11 is adjacent the bone or bone plate and the rivet can beadvanced into the hole no further. With the head of the rivet heldfirmly against the bone or a bone plate, tension is applied to theproximal end 42 of the core thereby urging the conical portion deeperinto the axial bore and expanding the legs 16 outwardly into contactwith the surrounding bone. When the shoulder 45 of the conical expansionportion 44 abuts the shoulder 15 in the rivet's axial bore 14, theconical portion can advance no further and the core 41 of the expansionpin breaks away from the conical expansion portion leaving the expandedrivet held securely in the hole. The outer surface 19 of the legs of therivet may be modified, as shown in FIG. 6, to provide a positiveattachment of the rivet to the bone. A suture 18 (FIG. 1) or a washer190 (FIGS. 18-20) connected to the head, neck, or another part of therivet, may be used to securely affix a substrate to the head of therivet and hence, the bone.

The rivet bone fastening device 10, described in FIGS. 1-6, can beadapted to receive an expansion pin which is inserted through theproximal end of the axial bore. Such an embodiment, referred to hereinas a “top-loading” rivet bone fastener, is indicated at numeral 70 inFIGS. 7, 8 and 9. FIG. 7 is a distal end view of the top-loading rivet70 in accordance with the present invention. FIG. 8 is a elevationalcross-sectional view, taken along section line 8—8 of FIG. 7,illustrating the top-loading embodiment of a rivet bone fastener. Thetop-loading rivet 70 has a proximal head end 81, a distal end 82, and abody portion 83 therebetween. The rivet 70 has a cylindrical axial bore84 coextensive with the length thereof, a portion of the axial borebeing tapered inwardly in the distal axial direction to form a conicalaxial bore 85. The body portion 82 of the rivet 70 includes at least twoexpandable legs, 86 a and 86 b, symmetrically disposed in opposition toone another with respect to the axial bore, and separated by one or moreslots 87. A portion of the axial bore 84 proximal to the conical axialbore 85 is constricted to form a shoulder detent 88. The body portion ofthe rivet may further include a circumferential groove 89 or similarmeans operable for attaching a suture to the rivet. A slot 90 in thebody portion of the rivet 70, illustrated at numeral 90 in the proximalend view of the rivet shown in FIG. 9, enables elastic deformation ofthe body portion of the rivet when an expansion pin 100 is inserted intothe proximal end of the rivet and advanced through the axial bore 84.

An expansion pin 100 adapted for use with the top-loading rivet 70 isillustrated in cross-sectional view in FIG. 10. The expansion pin 100 isa cylindrical member having a proximal end 101, a distal end 102 and abody portion 103 therebetween. A metallic extension portion 106, affixedto the proximal end 101 of the expansion pin 100, provides means forgrasping and manipulating the expansion pin for insertion into the axialbore 84 of the top-loading rivet 70. After the expansion pin 100 hasbeen expanded within a hole drilled in a bone, the extension portion 106of the expansion pin is preferably removed from the pin. The bodyportion 103 has a circumferential shoulder 104 near the proximal endthereof. A proximal end view of the expansion pin 100 is shown in FIG.11. A portion 105 of the body portion 103 of the expansion pin 100 nearthe distal end thereof, is tapered inwardly to present a smooth conicalouter surface. The proximal end of either the rivet or the expansion pinfurther includes substrate fastening means such as, for example, alength of either absorbable or non-absorbable suture affixed thereto.

In order to use the top-loading fastener 70 to attach a substrate suchas soft tissue or a bone plate to a bone, a hole dimensioned to receivethe body portion of the rivet is drilled into the bone. The distal end82 of the rivet 70 is inserted into the hole and the rivet is urgedinwardly until the rivet can be advanced no further. The distal end 102of the expansion pin 100 is inserted into the rivet's axial bore throughthe proximal end thereof and urged thereinto. The slot 90 permits theproximal end of the rivet to expand as the expansion advances into theaxial bore. When the circumferential shoulder 104 engages thecircumferential shoulder detent 88 in the axial bore, the legs 86 a and86 b of the rivet are fully expanded and the expansion pin is lockedwithin the axial bore by the matingly engaged shoulders 88 and 104. Asuture may be anchored to the rivet by attachment to the groove 89 onthe rivet. The free ends of the suture may be used to attach a substrateto the rivet. As stated above, the extension portion of the expansionpin is preferably metallic. If the portion of the expansion pin 100 towhich the extension portion 106 is affixed is bioabsorbable, theextension portion may be separated from the expansion pin by means of atool adapted to apply tension to the extension portion. If both theextension portion 106 and the body portion 103 of the expansion pin 100are metallic, it may be preferable to attach the extension portion tothe body portion by threaded or breakaway means to facilitatedisengagement thereof.

A particularly preferred embodiment of a rivet bone fastener isindicated at 120 in FIGS. 12-14. The rivet 120, shown in distal end viewin FIG. 12, includes an expansion pin 150 (FIG. 15) housed within theaxial bore which expands the legs of the rivet when rotated 90 degrees.With reference to FIG. 13, the particularly preferred embodiment of abone rivet 120 in accordance with the present invention, is shown inlongitudinal cross-sectional viewed along section line 13—13 of FIG. 12.The rotationally expandable rivet 120 has a proximal end 121, a distalend 122 and a body portion 123 therebetween; the body portion having anaxial bore 124 coextensive with the length thereof. The body portion 123has two or more legs 125 and 126 on the distal end thereof separated bya slot 127. The distal end of the axial bore 128 has an ellipticalcross-section as shown in FIG. 12 whereas the remainder of the axialbore 124 has a circular cross-section. A circumferential attachmentgroove 129 communicates with the proximal end of the rivet through asuture hole 130. In FIG. 12, two opposing detent grooves 131 and 132 areshown, which extend proximally from the elliptical distal end of theaxial bore and which are parallel to, and coextensive with the,elliptical bore 128. The purpose of the detent grooves will be discussedbelow. FIG. 14 illustrates the rivet 120 in proximal end view. The outeredges 140 of the proximal end of the rivet are preferably provided withmeans operable for preventing rotation of the rivet when a torque isapplied to the rivet.

A rotatable expansion pin 150 adapted for expansion of the rivet 120 isillustrated in elevational view in FIG. 15 and in distal end view inFIG. 16. The expansion pin 150 has a proximal end 152, a distal end 151and a shaft portion 153 therebetween. The proximal end 152 of the pin150 is most preferably square, having four flat orthogonal sides 154thereon which provide means operable for receiving a tool such as, forexample, a wrench, for rotating the pin 150 within the axial bore 124 ofthe rivet 120. The distal end 151 of the expansion pin 150 issubstantially elliptical in cross-section; having a dimension along amajor axis A and a minor axis B (FIG. 16) equal to or slightly less thanthe corresponding dimensions of the elliptical distal end 128 of theaxial bore in the rivet 120. The distal end 151 of the expansion pin 150preferably includes at least one, and more preferably two, protuberances161 and 162 extending laterally therefrom along the major axis A. Theprotruberances 161 and 162 are dimensioned to matingly engage thegrooves 131 and 132 in the axial bore 124 of the rivet 120 when the legs125 and 126 are expanded. The expansion pin 150 preferably includes acircumferential breakaway joint 155 proximal to the elliptical distalend 152 of the pin 150. The expansion pin 150 is rotationally disposedwithin the axial bore 124 of the rivet 120.

In operation, as with the previous rivet bone fasteners, a hole must bedrilled into the bone at a desired attachment site. The rivet 120, withthe expansion pin 150 rotatably mounted within the rivet's axial bore,is inserted into the hole and advanced thereinto until the expandablelegs of the rivet are completely within the hole. While preventing therivet from turning by employing suitable fixation means such as graspingthe proximal end thereof with a tool, the expansion pin 150 is rotated90 degrees, bringing the major axis of the elliptical distal end of thepin into alignment with the minor axis of the elliptical portion of theaxial bore. Further rotation of the pin is resisted when the major axisof the pin intersects the detent grooves adjacent to the ellipticalportion of the axial bore. At this point of rotation, the legs of therivet are fully expanded to engage the bone. The mid-portion of a lengthof suture may then be pressed into the circumferential groove 129 at theproximal end of the rivet and the free ends of the suture threadedthrough the hole 130. With the suture anchored to the rivet, the suturemay then be used to attach a substrate such as, for example, soft tissueto the rivet. The rivet and the expansion pin, or portions thereof, maybe fabricated from any biocompatible material, including both absorbableand non-absorbable.

In the case of both union and non-union bone fractures, when thesegments of bone comprising the fracture site are juxtaposed, healing isaccelerated by applying a compressive force to the fracture site. Priorart teaches the use of a bone plate, together with one or more screws,to provide a compressive force to a fracture site in order to stabilizethe fracture site and accelerate healing. In this procedure, a pilothole is first drilled through both sections of the fractured bonecomprising the fracture site. The pilot hole in the proximal section ofthe fractured bone is then enlarged, and the distal portion of the pilothole tapped to matingly engage the screw thread. A bone plate isfastened to the bone by means of the screw and the screw advanced intothe tapped pilot hole until the bone plate compresses the fracture site.This technique is time consuming and there may be occasions when accessto the screw head, in order to apply a torque thereto, is obstructed byanother anatomical structure. In such a case, it may not be possible toapply the desired compressive force.

Turning now to FIG. 17, an alternative method, in accordance with thepresent invention, for applying a compressive force to a fracture siteemploys the use of a compression rivet 170. The compression rivet 170has a distal end 171 comprised of at least two expandable legs 172 and173, an axial bore 174, and a proximal end 175 having ratcheting means176 on the outer surface thereof. The compression rivet 170 includes abone insertion portion 177 and a ratcheting portion 178. The boneinsertion portion 177 of the rivet 170 may be configured in accordancewith any of the embodiments of a rivet bone fasteners 10, 70 or 120,discussed earlier, using their respective expansion pins 40, 100 and 150to expand the legs thereof. The proximal ratcheting portion 178 of thecompression rivet is, however, absent in the rivet bone fastenersdiscussed previously. The ratcheting portion 178 includes ratchetingmeans, such as, for example, a plurality of annular grooves 176circumscribing the ratcheting portion 178 of the compression rivet.

In order to use the compression rivet 170 to stabilize and compress afracture site, the site is first exposed as illustrated in FIG. 18. Thesegments of bone 180 and 181 are brought into juxtaposition and a hole182 is drilled. The distal bone insertion portion 177 of the compressionrivet is then inserted into the hole, and the legs 172 and 173 expandedby means an expansion pin operable for performing this function. Awasher 190, shown in top view in FIG. 19, and cross-sectional view inFIG. 20, having a central aperture 191 and a plurality of flanges 192projecting into the aperture, is advanced in a distal direction alongthe ratcheting portion 178 by means of pressure thereon exerted by asuitable tool (not shown). When the bone-facing surface 183 of thewasher 190 abuts the bone 181, and can be advanced no further, the bonesegments 181 and 182 are both stabilized and held in juxtaposition alongthe fracture line 184 by a compressive force exerted by the washer 190.The flanges 192 on the washer lockingly engage the racheting means 176on the outer surface of the ratcheting portion 178 of the rivet 170thereby preventing the washer from moving in a distal direction. Thewasher compresses the fractured portions of bone against one anotherthereby accelerating the fracture healing process.

A tool useful for inserting a top-loading rivet in accordance with thepresent invention into a hole drilled in a bone is shown in elevationalcross-sectional view at 210 in FIG. 21 and front and rear end views inFIGS. 22 and 23 respectively. The tool 210 has a distal rivet graspingend 211 and a proximal end 212 and a barrel 213 therebetween having anaxial bore 214. With the proximal end 81 of the top-loading rivet 70held securely within the distal end 211 of the tool 170 by suitablerivet grasping means, the distal end 82 of the rivet bone fastener isinserted into a hole drilled in a bone. The distal end 241 of a plunger240 (FIG. 24) is inserted into the proximal end 212 of the barrel 214and advanced until the distal end 241 is in contact with the proximalend 101 of the expansion pin 100. Squeezing rotatably mounted trigger215 forces the expansion pin 100 into the axial bore 84 of thetop-loading rivet 70 thereby expanding the legs 86 a and 86 b thereof topress against the surrounding bone. The proximal end 81 of the rivet 70is released when the trigger 215 returns to its initial position. Asdiscussed earlier, in the event that the body portion 103 of theexpansion pin 100 is bioabsorbable and the extension portion 106 ismetallic, the tool 210 further includes means adapted to apply tensionto the extension portion, following leg expansion, in a quantitysufficient to separate the extension portion 106 from the body portion103.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. For example, thedistal end 151, while preferably elliptical in cross-section, can bemade in a variety of geometries, any of which will force the legs of therivet to expand when the expansion pin is rotated through an angle. Theessential element of the rivet 120 and the rotational expansion pin 150is that the legs of the rivet are expanded by rotating the pin. It istherefore intended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What I claim is:
 1. A rivet bone fastener for fixation within a holedrilled in a bone comprising: (a) a rivet having a proximal end, adistal end and an elongate body portion therebetween, said body portionhaving a length, and an axial bore coextensive with said length, saidaxial bore comprising a non-cylindrical distal portion and a cylindricalproximal portion, said body portion having a plurality of expandablelegs disposed adjacent to said non-cylindrical distal portion of saidaxial bore; (b) an expansion pin having a cylindrical proximal end and anon-cylindrical distal end, rotatably mounted within said axial bore,and wherein rotation of said expansion pin within said axial boreexpands said expandable legs of said rivet outwardly.
 2. The rivet bonefastener in accordance with claim 1 wherein said rivet further comprisessubstrate fastening means affixed thereto, said substrate fasteningmeans being operable for attaching a substrate to said rivet.
 3. Therivet bone fastener in accordance with claim 1 wherein said expansionpin further comprises substrate fastening means affixed thereto, saidsubstrate fastening means being operable for attaching a substrate tosaid rivet.
 4. The rivet bone fastener in accordance with claim 1wherein said rivet is bioabsorbable.
 5. The rivet bone fastener inaccordance with claim 1 wherein said expansion pin is bioabsorbable. 6.The rivet bone fastener in accordance with claim 1 wherein said proximalcylindrical portion of said expansion pin further comprises rotationmeans integral therewith, said rotation means being adapted to receive atool operable for rotating said expansion pin.
 7. The rivet bonefastener in accordance with claim 2 wherein said proximal cylindricalportion of said expansion pin further comprises rotation means integraltherewith, said rotation means being adapted to receive a tool operablefor rotating said expansion pin.
 8. The rivet bone fastener inaccordance with claim 3 wherein said proximal cylindrical portion ofsaid expansion pin further comprises rotation means integral therewith,said rotation means being adapted to receive a tool operable forrotating said expansion pin.
 9. The rivet bone fastener in accordancewith claim 1 wherein said non-cylindrical portion of said expansion pinand said non-cylindrical distal portion of said axial bore have anelliptical cross-section when viewed in the direction of the axial bore.10. The rivet bone fastener in accordance with claim 2 wherein saidsubstrate fastening means is a suture.
 11. The rivet bone fastener inaccordance with claim 3 wherein said substrate fastening means is asuture.
 12. The rivet bone fastener in accordance with claim 2 whereinsaid proximal cylindrical portion of said expansion pin furthercomprises rotation means integral therewith, said rotation means beingadapted to receive a tool operable for rotating said expansion pin. 13.The rivet bone fastener in accordance with claim 2 wherein saidnon-cylindrical portion of said expansion pin and said non-cylindricaldistal portion of said axial bore have an elliptical cross-section whenviewed in the direction of the axial bore.
 14. A rivet bone fastener forfixation within a hole drilled in a bone comprising: (a) a rivet havinga proximal end, a distal end and an elongate body portion therebetween,said body portion having a length, and an axial bore coextensive withsaid length, said axial bore defining an axial bore direction, saidaxial bore comprising a elliptical distal portion and a cylindricalproximal portion, said body portion having a plurality of expandablelegs disposed adjacent to said elliptical distal portion of said axialbore; (b) a rotational expansion pin having a cylindrical proximal endand a non-cylindrical distal end, rotatably mounted within said axialbore, and wherein rotation of said expansion pin within said axial boreexpands said expandable legs of said rivet outwardly; (c) rotationaldetent means disposed on a inner axial bore-facing surface of saidexpandable legs operable for engaging said elliptical distal portion ofsaid expansion pin when said expandable legs are fully expanded toresist further rotation of said rotational expansion pin.